510(k) · Cleared

Cleared

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter

K232190510(k) SpecialCleared Aug 22, 202329-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · DQY Catheter, Percutaneous

Cleared on Aug 22, 2023 as substantially equivalent to K051846 (Medtronic Vascular, 2005) after a 29-day review. Its family tree reaches back 4 generations to 1998. 1 of the 6 devices in its family, counting itself, has a Class I recall.

Decided: Aug 22, 2023
Review: 29 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K981198 (1998). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
3 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
2 generations backK042489 6F Z4 Guide CatheterMedtronic Vascular · 2004 · Recalled (Class I)
1 generation backK051846 7F Sherpa NX Guide CatheterMedtronic Vascular · 2005
This deviceK232190 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide…Medtronic Vascular · 2023

Class I recalls in this family

K042489 6F Z4 Guide Catheter2 generations back · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K981198	Medtronic Zuma Guiding Catheter	Medtronics Interventional Vascular	1998	25
−3	K021256	Z3 Guide Catheter	Medtronic Vascular	2002	52
−2	K042489	6F Z4 Guide Catheter	Medtronic Vascular	2004	Class I
−1	K051846	7F Sherpa NX Guide Catheter	Medtronic Vascular	2005	—
0 (this device)	K232190	6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter	Medtronic Vascular	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K232190, 1998–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K051846	7F Sherpa NX Guide Catheter Summary page 5 …atheters 6F and 7F 1 Predicate Device: 510(k) Number Device Name Manufacturer Product Code K051846 (2005) 7F Sherpa NX Medtronic Vascular DQY Balanced Guide Cathete…	Medtronic Vascular	2005	—
†	K042489	6F Z4 Guide Catheter	Medtronic Vascular	2004	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K0424896F Z4 Guide CatheterMedtronic Vascular · 2004 · 2 generations back · ◆ on the line of descent in FIG. 1191 Class I recalls

What does this lineage say?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
4 of the 5 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Guide Catheter is intended to be used in the coronary or peripheral vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K232190 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232190: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232190

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026